Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes (TRACK-D)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Chronic Kidney Disease	Drug: rosuvastatin	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2998 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient
Study Start Date :	December 2008
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	November 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; perioperative rosuvastatin administration for at least 5 dosages	Drug: rosuvastatin; rosuvastatin
Placebo Comparator: control; blank control of perioperative statin administration	Drug: rosuvastatin; rosuvastatin

Outcome Measures

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Primary Outcome Measures :

1. An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure [ Time Frame: 72 h ]

Secondary Outcome Measures :

1. The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes. [ Time Frame: 30 d ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Planned diagnostic coronary or peripheral artery angiography
• T2DM
• CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
• Statin naive, or not on statin treatment for at least 14 days
• Withdrawal metformin or aminophylline for 48h before angiography
• Total iodixanol volume

Exclusion Criteria:

• Hypersensitivity to iodine-containing compounds and statins
• Type 1 diabetes mellitus
• Ketoacidosis
• Lactic acidosis
• CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR＜30ml/min per 1.73m2)
• STEMI
• NYHA class IV or hemodynamic instability
• Administration of any iodinated CM within 14 days before randomization
• LDL-C＜1.82mmol/L（70mg/dL）
• Hepatic dysfunction (ALT 3 times greater than upper normal limit)
• Thyreoid insufficiency
• renal artery Stenosis(unilateral ＞70％ or bilateral stenosis＞50％)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 53 Study Locations

Sponsors and Collaborators

Shenyang Northern Hospital

Investigators

Principal Investigator:	Yaling Han, MD	Shenyang Northern Hospital

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Li J, Li Y, Wang X, Yang S, Gao C, Zhang Z, Yang C, Jing Q, Wang S, Ma Y, Wang Z, Liang Y, Han Y. Age, estimated glomerular filtration rate and ejection fraction score predicts contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease: insight from the TRACK-D study. Chin Med J (Engl). 2014;127(12):2332-6.

Han Y, Zhu G, Han L, Hou F, Huang W, Liu H, Gan J, Jiang T, Li X, Wang W, Ding S, Jia S, Shen W, Wang D, Sun L, Qiu J, Wang X, Li Y, Deng J, Li J, Xu K, Xu B, Mehran R, Huo Y. Short-term rosuvastatin therapy for prevention of contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease. J Am Coll Cardiol. 2014 Jan 7-14;63(1):62-70. doi: 10.1016/j.jacc.2013.09.017. Epub 2013 Sep 26.

Responsible Party:	Han Yaling, MD, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:	NCT00786136 History of Changes
Other Study ID Numbers:	SYNH-20081028
First Posted:	November 6, 2008
Last Update Posted:	April 10, 2013
Last Verified:	April 2013

Keywords provided by Han Yaling, MD, Shenyang Northern Hospital:

diabetes mellitus; chronic kidney disease; contrast induced acute kidney injury; angiography

Additional relevant MeSH terms:

Diabetes Mellitus; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Renal Insufficiency	Rosuvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors